Open Access

Vascular damage develops with diverging severity during and after percutaneous coronary intervention with stent placement and is the prevailing stimulus for in-stent restenosis. Previous work has failed to link mechanical data obtained in a realistic in vivo or in vitro environment with data collected during imaging processes. We investigated whether specimens of porcine right coronary arteries soften when indented with a stent strut shaped structure, and if the softening results from damage mechanisms inside the fibrillar collagen structure. To simulate the multiaxial loading scenario of a stented coronary artery, we developed the testing device ‘LAESIO’ that can measure differences in the stress-stretch behavior of the arterial wall before and after the indentation of a strut-like stamp. The testing protocol was optimized according to preliminary experiments, more specifically equilibrium and relaxation tests. After chemical fixation of the specimens and subsequent tissue clearing, we performed three-dimensional surface and second-harmonic generation scans on the deformed specimens. We analyzed and correlated the mechanical response with structural parameters of high-affected tissue located next to the stamp indentation and low-affected tissue beyond the injured area. The results reveal that damage mechanisms, like tissue compression as well as softening, fiber dispersion, and the lesion extent, are direction-dependent, and the severity of them is linked to the strut orientation, indentation pressure, and position. The findings highlight the need for further investigations by applying the proposed methods to human coronary arteries. Additional data and insights might help to incorporate the observed damage mechanisms into material models for finite element analyses to perform more accurate simulations of stent-implantations.

Finite element (FE)–based studies of preoperative processes such as folding,pleating, and stent crimping with a comparison with experimental inflation tests are not yet available. Therefore, a novel workflow is presented in which residual stresses of balloon folding and pleating, as well as stent crimping, and the geometries of all contact partners were ultimately implemented in an FE code to simulate stent expansion by using an implicit solver. The numerical results demonstrate that the incorporation of residual stresses and strains experienced during the production step significantly increased the accuracy of the subsequent simulations, especially of the stent expansion model. During the preoperative processes, stresses inside the membrane and the stent material also reached a rather high level. Hence, there can be no presumption that balloon catheters or stents are undamaged before the actual surgery. The implementation of the realistic geometry, in particular the balloon tapers, and the blades of the process devices improved the simulation of the expansion mech-anisms, such as dogboning, concave bending, or overexpansion of stent cells. This study shows that implicit solvers are able to precisely simulate the mentioned preoperative processes and the stent expansion procedure without a preceding manipulation of the simulation time or physical mass.

Arteriosclerosis is a major health issue worldwide. While it is commonly treated by the implantation of an balloon-expandable stent, micro injuries may occur during stent deployment, and induce in-stent restenosis, whose consequence can be fatal. Studying this undesirable phenomenon is usually limited as experimental data is hard to obtain on ethical ground. Numerical simulation are performed to better understand this problem. To construct a more realistic simulation of a balloon-expandable stent, a partitioned strongly-coupled FSI simulation of the balloon deployment was set up using the ICFD solver of LS-DYNA, - a quite innovative approach. The complex balloon configuration as well as the interaction of the injection medium and the balloon structure was considered. The balloon structure consisting of shell elements was obtained from preliminary balloon folding and pleating simulations. The balloon consists of a flexible thin walled polyamide. The injection fluid is implemented using volume elements. Balloon deployment was initiated by a pressure boundary condition inducing a volume flow into the balloon. The initial feasibility analysis showed promising result including a continuous balloon deployment and a reasonable development of the fluid pressure and velocity field. However, applying this FSI approach to a more complex balloon structure led to a non convergent solution. The non-convergence could be mainly reduced to mechanical factors including the low wall thickness of the balloon (< 0.05 mm) and the flexibility of the polyamide. Further, the ICFD solver shows less accuracy concerning the FSI conditions when dealing with thin flexible structures as well as enclosed volumes. A shell thickness of 0.06 mm is believed to result in a convergent solution.